Menu
Recruiting NCT07310095

A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)

Phase IV Interventional Crohn Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guselkumab (GUS).
Who it may be relevant to
Registry conditions: Crohn Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab

Overview

The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.

Interventions

  • Drug Guselkumab (GUS)
    Guselkumab will be administered intravenously or by subcutaneous injection.

Primary outcome measures

  • Percentage of Participants Achieving Clinical Remission At Week 48 [Time frame: At Week 48]
Secondary outcome measures (11)
  • Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48 [Time frame: At Weeks 12, 24 and 48]
  • Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24 [Time frame: At Weeks 12 and 24]
  • Percentage of Participants Achieving Endoscopic Response [Time frame: At Weeks 24 and 48]
  • Percentage of Participants Achieving Endoscopic Remission [Time frame: At Weeks 24 and 48]
  • Baseline Characteristics of Participants With Endoscopic Remission: Age [Time frame: Baseline]
  • Baseline Characteristics of Participants With Endoscopic Remission: Sex [Time frame: Baseline]
  • Baseline Characteristics of Participants With Endoscopic Remission: Height [Time frame: Baseline]
  • Baseline Characteristics of Participants With Endoscopic Remission: Weight [Time frame: Baseline]
  • Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications [Time frame: Baseline]
  • Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities [Time frame: Baseline]
  • Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Has a confirmed diagnosis of Crohn's disease (CD)
  • Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220 and either mean daily stool frequency (SF) count >= 4 or mean daily abdominal pain (AP) score >=2
  • Participants had received at least two doses of ustekinumab (UST) (induction of 6 milligram \[mg\]/kilogram \[kg\] intravenous \[IV\] followed by 90 mg subcutaneous \[SC\] at week 8) as the instruction manual
  • Initially responded to UST induction therapy and then lose response to UST
  • During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic

Exclusion criteria

  • Have responded well to treatment with UST in a dosing regime that is not in line with to the approved recommended dosing (for example, multiple intravenous induction) experienced optimized treatment with UST(not as instruction manual)
  • Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months
  • Is currently enrolled in an interventional clinical study
  • Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome
  • Have a current or be suspected to have an abscess

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • The First Affiliated Hospital Sun Yat sen University — Guangzhou
  • The Sixth Affiliated Hospital Sun Yat sen University — Guangzhou
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou
  • The First Affiliated Hospital of Anhui Medical University — Hefei
  • Ruijin Hospital — Shanghai

Identifiers

NCT: NCT07310095 · CNTO1959CRD4007 · CNTO1959CRD4007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗